BEUDAMED
    FDA Adverse Event Other Summary report: N

    CARDINAL

    MDR report key: 768099 · Received October 9, 2006

    Report

    Report Number
    MW1040635
    Event Type
    Other
    Date Received
    October 9, 2006
    Date of Event
    August 16, 2006
    Report Date
    October 9, 2006
    Manufacturer
    INVERNESS MEDICAL
    Product Code
    GTY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    WE HAD AN INCIDENT WHERE OVER THIRTY PEOPLE HAD POSITIVE STREP TESTS IN ONE DAY. THIS SEEMED ODD AS MOST OF THE INDIVIDUALS WERE EMPLOYEES OR OUR HEALTH CENTER, AND THERE WAS NO REASON TO BELIEVE THIS WAS AN EPIDEMIC OF ANY KIND. WE PERFORMED CONTROLS TWICE ON OUR TEST KIT THAT DAY, AND IT PERFORMED NORMALLY. HOWEVER, WE DECIDED TO BACK UP A NUMBER OF THE POSITIVE TESTS WITH CULTURES. THESE WERE OUR RESULTS: CULTURE + -, RAPID STREP + 0 11, RAPID STREP - 0 5 16, SPECIFICITY = 5/16 = 31%. THE STATED SPECIFICITY OF THE TEST IS 99% RANGE 97.6, 100% POSITIVE PREDICTIVE VALUE FOR THE TEST WAS 0. THE MFR IS INVERNESS MEDICAL. PRODUCT CODE IS 6210KCA. TEST NAME SP STREP A DIPSTICK LOT #93914 EXP 12/07. THEY PERFORMED THREE NEGATIVE CONTROLS USING RETENTION DEVICES AND THEY ALL PERFORMED NORMALLY. I SUSPECT THAT THERE IS SOMETHING ELSE GOING ON -- CROSS REACTIVITY WITH ANOTHER ANTIGEN PERHAPS. CLEARLY THERE IS SOMETHING WRONG WITH THE IN VIVO PERFORMANCE OF THIS TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDINAL SP STREP A DINSTICK GTY INVERNESS MEDICAL 6210KCA 93914

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other